DOCUMENTATION

Essential (Regulatory) documents are "...those which enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and show whether the trial is, or has been, conducted in accordance with the applicable regulatory requirements"

Initial Regulatory documents are needed in order to officially take on the protocol and they must be submitted and approved by multiple parties including Sponsor, Review Board, CRO, etc.

These documents state how the site and personnel will handle the protocol and its procedures by delegating the scope of work among the team.